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PRAKTEK ASUHAN KEPERAWATAN BERBASIS BUKTI ILMIAH DAN UPAYA MENCEGAH

MEDICATION ERROR DI ICU

Akrom IMANY – PROKAMI Yogyakarta

ADDICC UAD akmaa_uad@yahoo.co.id

Pelatihan Manajemen keperawatan di Intensive Care Unit (ICU) Rumah Sakit

YOGYAKARTA, 19-22 Juni 2014

Objective: Dapat menjelaskan konsep dasar ebm, dan gambaran kejadian medication error di ICU serta pentingnya pencegahan medication error di ICU

Dapat menjelaskan tahapan dalam ebm

Dapat menyusun PICO

Dapat menentukan level of evidence drug literature

Dapat menyebutkan web site ebm

Dapat melakukan critical appraisal dan menjelaskan penerapan konsep EBM di ICU

Introduction

Apakah latar belakang yang mendasari lahirnya EBM di kedokteran? Bagaimana di ICU?

Apakah EBM?

Apakah urgensinya?

Bagaimana gambaran aplikasinya?

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Introduction

Opinion based v.s. evidence based medication

Harm v.s. safety

Law and legal formal

Economic beneficity

Introduction: Error medicine

Leape L. Error in Medicine. JAMA 1994

– 4% of all hospital stays

– mortality rate of14%

Committee on Quality of Health Care in America, Institute of Medicine. 2000.

– Death related to adverse events:

44000 à 98000 patients each year

8th cause of mortality

(Camphbel et al., 2008)

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MEDICATION ERROR, PREVENTABILITY AND MORBIDITY LEVEL

Hepler & Segal, 2003

(Camphbel et al., 2008)

MEDICATION ERROR IN PROCESS

Hepler & Segal, 2003

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ORIGINATION MEDICATION ERROR

(Camphbel et al., 2008)

Unintended Event : An occurrence that harmed or could have harmed a patient SEE: multicenter, multinational, single day study in ICU Reporting by all ICU staff members : Voluntarily – Anonymously - Confidential

INTRODUCTION : ERROR IN ICU?

Selected Events

• Medication wrong drug, dose, or route

• Airway unplanned extubation

artificial airway obstruction

cuff leakage

• Lines, Drains dislodgement

Catheters inappropriate opening/disconnection

• Equipment power supply, oxygen supply,

failure ventilator, infusion pump

• Alarms inappropriate turn off

SEE STUDY

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SEE Study – participating Countries

1

1

1

1

1

1

1

1

1

1

1

2

2

2

2

2

2

3

6

7

7

8

11

12

14

19

22

27

28

35

0 5 10 15 20 25 30 35 40

Australia

USA

Estonia

Indonesia

Macedonia

Norway

Poland

Romania

Singapore

Latvia

Slovakia

Albania

Finland

Brasil

Belgium

Netherlands

Slovenia

Hongkong

Greece

DenmarkIndia

France

Switzerland

Germany

Czech Republic

SpainPortugal

UK

Austria

Italy

Number of ICUs

220 ICUs in 29 countries

2090 patients

Adults

Patients: 1913

Sex: 61 % m / 39 % w

Age (mean): 62,3 ± 16,3 (18 – 99 a)

NEMS (median): 27 (18;38)

SOFA (median): 4 (2;7)

Events: 584

Pts with 1 Event: 393

At least 1 sentinel event: 73% of ICUs

SEE STUDY

20 pts22 pts81 pts

268 pts

1522 pts

0

10

20

30

40

50

60

70

80

90

0 1 2 3 >3

# of events

Perc

en

t

# of events in patients (adults)

SEE STUDY

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Alarms

n=17 Lines,

Drains,

Catheters

n=158

Medication

n=136

Equipment

n=112

Airway

n=47

391 affected patients

SEE STUDY

Events /

100 pt days

lower

95% CI

upper

95% CI

All 38.8 34.7 42.9

Lines, drains 14.5 12.0 16.9

Medication

Prescription

Administration

10.5

5.7

4.8

8.6

4.4

3.6

12.4

7.1

6.0

Equipment 9.2 7.4 11.1

Airway 3.3 2.4 4.3

Alarms 1.3 0.6 1.9

SEE STUDY

Variables in

final model

Unexplained

variables

SEE study

Explanatory power of measured variables

risc-timeorganfailures

ICU as random

component

nems

intervention

icu

patients per nurse

Explanatory power within the final model

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Time - pattern of events

0

5

10

15

20

25

30

35

40

45

50

D1

06-0

7

07-

08

08-

09

09-

10

10

-11

11

-12

12-

13

13-

14

14-

15

15-

16

16-

17

1

7-18

1

8-19

1

9-20

2

0-21

2

1-22

2

2-23

2

3-24

D2

00-0

1

01

-02

02-0

303

-04

04-0

505

-06

06-0

7

# o

f e

ve

nts

A look into the nature and causes of human errors in the ICU Donchin et al, Crit Care 1995

SEE study

SEE study

0

2

4

6

8

10

12

14

16

Airway

Drug prescription

Drug administration

Lines, catheters

Equipment

Alarms Drug prescription

Drug administration

Information

www.hsro-esicm.org

Contact:

andreas.valentin@meduniwien.ac.at

SENTINEL EVENTS EVALUATION (SEE)

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Adverse events in ICU

Frequent and in relation with

Severity of the patients

Procedures

Impact on : (Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA,

2003, 290:1868-1874)

Morbidity and mortality

Finance :

Iatrogenic pneumothorax : 17,312 US$

DVP and post operative pulmonary emboli : 21,709 US$

Legal issues

Psychology of the team

Preventability ?

If you hear this

“I am proud to say that I have no adverse

event in my ICU”

You should conclude that this is a very dangerous

ICU

No documentation of events

No evaluation

No corrective action

May be even no patient in that ICU……

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※ Use of current best evidence in making decisions about

the care of individual patients.

Ø Evidence-based medicine (EBM) is the process of systematically reviewing, appraising and using clinical research findings to aid the delivery of optimum clinical care to patient (www.bandolier.com)

※ Not only a skill but also an attitude change

※ Conscientious, explicit, and judicious use of current best evidence in making decisions about individual patients. ~ Archie Cochrane 1972

E B M

An updated model for evidence-based clinical decisions.

Clinical expertise - Art of medicine

Clinical state and circumstances (what’s wrong, what are the options)

Patients’ preferences and actions

Research evidence

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Piramida evidence dan Desain Penelitian

Animal research

In vitro (test tube) research

Case series/Reports

Ideas, Editorials, Opinions

Case Control Studies

Cohort studies

Randomized Controlled Studies

Randomized Controlled Double Blind Studies

Meta

- an

aly

sis Level of evidence Study design

Resources drug literature/medicinal

literature PUBMED

McMaster University HIRU（Health Information Research Unit）Cochrane Collaboration http://hiru.mcmaster.ca/

Oxford University Centre for Evidence-Based Medicine http://cemb.jr2.ox.ac.uk

American College of Physician（ACP）， ACP Journal Club Online http://www.acpjc.org

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1. Clinical Question : Patient-focused, problem-oriented

2. Find Best Evidence: Literary Search

3. Critical Appraisal : Evaluate evidence for quality and usefulness

4. Apply the Evidence : Implement useful findings in clinical practice

5. Evaluate : The information, intervention, and EBM process

THE FIVE BASIC STEPS OF EBM

Step 1. Converting the need for information (about prevention, diagnosis, prognosis, therapy, causation, etc.) into an answerable question or PICO.

Step 2. Searching the best evidence with which to answer that question.

Step 3. Critically appraising the evidence for its validity (closeness to the truth), impact (size of the effect), and applicability (usefulness in our clinical practice).

Step 4. Integrating the evidence with our clinical expertise and patients’ unique biology, values and circumstances.

Step 5. Evaluating our effectiveness and efficiency in executing steps 1-4 and seeking ways to improve them both for next time.

Five Steps to Practice EBM

STEP I: ASKING ANSWERABLE CLINICAL

QUESTION

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Types of Clinical Questions

Diagnosis

Therapy

Etiology

Prognosis

Background

Foreground

By Content By Format

PERTANYAAN “Foreground”

Ask for specific knowledge about managing patients with a disorder

Have four (or three) essential components:

1. Patient and/or problem

2. Intervention (treatment)

3. Comparison intervention

4. Clinical outcomes

Patient ~ Who is the patient or what is the problem being addressed?

Intervention ~ What is the intervention?

Comparison ~ What are the alternatives?

Outcome ~ What are the outcomes?

Foreground question: There are four elements of a well-formulated

question

PICO METHODE

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MERUMUSKAN PERMASALAHAN METODE PICO?

PICO EBM process asks the doctor to consider

Example

Patient What patient population he or she is interested in?

Patient is female caucasian child with ear infection

Intervention What tests, what treatments could be considered?

Antibiotics

Comparison alternatives to consider? No treatment

Outcome what the outcome of interest is (and how is it to be measured)

Ear infection reduced

Step 1 of the EBM process: formulate a sensible, focused clinical question – use PICO methods

atau

Ex. Asking Answerable Clinical Question

Patient/Problem Insulin-dependent diabetics

Intervention Intensive insulin regimen

Comparison Regular insulin regimen

Outcomes Retinopathy Symptomatic hypoglycemia

In the insulin-dependent diabetics, does intensive insulin regimen or

Regular insulin regimen lead to symptomatic hypoglycemia?

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KASUS 1

Meurut Saudara perlu atau tidakkah pengontrolan GDS pada semua pasien di ICU? Ataukah pasien kritis yang memiliki riwayat DM yang perlu dikontrol GDSnya? Apakah dasar bukti ilmiah pendapat Saudara?

Bagaimana langkah Saudara dalam mencari bukti ilmiah?

Bagaimana mana Saudara menyusun permasalahan klinis dan apakah PICOnya ?

Kasus 2

Penggunaan kortikosteroid pada pasien ARDS masih diperdebatkan efikasinya. Bagaimana menurut Saudara? Apa dasar bukti ilmiah pendapat Saudara?

Susunlah rumusan permasalahan penggunaan kortikosteroid pada ARDS dan apakah PICOnya?

STEP II: SEARCHING THE BEST

EVIDENCE

WEB SITE – SOURCE OF DRUG LITERATURE

CRITICAL THINKING – APPRAISAL DRUG LITERATUR

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Searching The Best Evidence

(primary journals or databases) ~ Medline, NEJM, Lancet…

(secondary journals or databases) ~ ACP journal club, Cochrane.

(level of evidence) 。

TEXT BOOK OF EBM

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WEBSITE OF EBM PubMed: http://www.ncbi.nlm.nih.gov/PubMed/

1. ACP Journal Club: http://www.acpjc.org/ (1-4, 7)

2. Cochrane ~ DARE (Database of Abstracts of Reviews of Effects)

3. CDSR (Cochrane Database of Systematic Reviews) ~ Collaborative Review Groups http://www.cochrane.org/cochrane/revabstr/crgindex.htm

4. CCTR (Cochrane Central Register of Controlled Trials):

5. Cochrane collaberation

6. NGC (National Guideline Clearinghouse): http://guideline.org

7. Micromedex (CCIS)

8. Centre for Evidence-Based Medicine: http://www.cebm.net/ = http://cemb.jr2.ox.ac.uk

9. McMaster UniversityHIRU（Health Information Research Unit）Cochrane Collaboration: http://hiru.mcmaster.ca/

10. American College of Physician（ACP）: http://www.acponline.org

11. Bandolier: http://www.ebandolier.com = http://www.jr2.ox.ac.uk/bandolier/

12. AHRQ website: http//www.ahrq.gov

13. InfoPOEMs: http://www.infopoems.com

14. Other resources: http://www.google.com.tw/ www.yahoo.com/ http://www.mdconsult.com/

15. (HINT): http://www.hint.org.tw

LATIHAN 2

SEARCHING JOURNAL SEBAGAI BUKTI ILMIAH

KASUS 1

Apakah kata kunci dan alamat sumber pustaka dimana Saudara akan mencari bukti ilmiah yang Saudara butuhkan sebagaimana permasalahan pada kasus 1?

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Kasus 2 Penggunaan kortikosteroid pada pasien ARDS masih diperdebatkan efikasinya. Bagaimana menurut Saudara? Apa dasar bukti ilmiah pendapat Saudara?

Apakah kata kunci dan alamat sumber pustaka dimana Saudara akan mencari bukti ilmiah yang Saudara butuhkan sebagaimana permasalahan pada kasus 2?

Critical appraisal drug literature:

1. Apakah informasinya valid?.....Drug literature and Level of evidence

2. Apakah informasinya penting?... Menghitung parameter outcome clinic

3. Apakah informasinya bermanfaat? …..menilai aplikabilitas

Strength of Evidence I Strong evidence from at least one systematic review of

well designed randomized controlled trials

II Strong evidence from at least one properly designed randomized controlled trial of appropriate size

III Evidence from well designed trials without randomization: single group pre-post, cohort, time series or matched case-controlled studies

IV Evidence from well designed non-experimental studies from more than one centre or research group

V Opinions of respected authorities, based on clinical evidence, descriptive studies or reports of expert committees

VI Someone once told me

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The Evidence Pyramid

Animal research

In vitro (test tube) research

Case series/Reports

Ideas, Editorials, Opinions

Case Control Studies

Cohort studies

Randomized Controlled Studies

Randomized Controlled Double Blind Studies

Meta

- an

aly

sis Grade of Recommendation

Level of Evidence

Therapy

[A] 1a Systemic review of RCTs

1b Single RCT

1c ‘All-or-none’

[B] 2a Systemic review of cohort studies

2b Cohort study or poor RCT

2c ‘Outcomes’ research

3a Systemic review of case-control studies

3b Case-control study

[C] 4 Case series

[D] 5 Expert opinion, physiology, bench research

What type of evidence best addresses the question, problem or issue? CLINICAL PRACTICE APPROPRIATE DESIGN FOR CLINICAL RESEARCH Diagnosis, Dx testing Cross-sectional study – not randomized trial Prognosis Follow-up studies of patients evaluated at same early point of illness Therapy, treatment RCT or Systematic review of multiple RCTs must be used

Avoid non-experimental approaches to avoid false conclusions about efficacy Exceptions: When treatment may be successful in an otherwise fatal condition When no studies are available (rare conditions, new treatments, etc.)

Harm RCT, Cohort, Case-control OTHER INFORMATIONAL Explore hypothesis Qualitative research History-taking Case control study Individual trial & error n of 1 trial Following clinical course Cohort study Recordkeeping Systematic registry-based (computer supported) research Quality of Care research Individual peer review, Process Evaluation MISCELLANEOUS Basic Science, Genetics, Immunology, etc.

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Menilai tingkat kepentingan informasi

Informasi dari jurnal ilmiah yang valid ada 2 jenis yaitu

Penting Tidak penting

Bagaimana menilainya?

MENILAI TINGKAT KEPENTINGAN DATA/INFORMASI

JURNAL ILMIAH

Lakukan perhitungan parameter outcome:

1. jurnal dengan design RCT/uji kemanjuran: hitung NNT/ARR/RR apabila skala pengukurannya nominal tetapi utk yang skala pengukurannya ratio lihat nilai p (signifikansi)

2. jurnal dengan design kohort/uji prognosis hitung nilai RR/NNT

3. jurnal dengan design cross sectional/case control/uji diagnosis hitung nilai OR/

Menilai tingkat kepentingan informasi

yang disajikan jurnal lmiah

EER= A/A+B=150/1000=15%

CER=D/C+D=100/1000=10%

ARR=EER-CER=15%-10% =5%

NNT=1/ARR=1/5%=20

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Latihan 3:

Tentukan level of evidence dari jurnal ilmiah yang Saudara peroleh untuk kasus 1 dan kasus 2

LATIHAN 4:

Bagaimana menghitung outcome atau menilai tingkat kepentingan informasi dari jurnal ilmiah yang Saudara peroleh?